Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot. (DEFI)

Össur

Status: Enrolling

Conditions: Amputation

Treatments: Device: Class III ESAR Foot evaluation; Device: PRO-FLEX PIVOT Foot evaluation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06627361

2023-A01374-41

Details and patient eligibility

About

The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:

1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
2. The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
3. An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.

The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult patient (over 18 years of age)

• Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot.
• Regularly using (more than 8 hours/day) a class III ESAR foot
• Functional class (CNEDiMTS indication)1
• Insured person.
• Able to answer questionnaires.
• Providing informed and written consent to participate in the study.
• Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation.
• Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score)

Exclusion criteria

• Bilateral lower limb amputation
• Femoral amputation
• Wearing a temporary prosthesis
• Change of socket or suspension system planned during the study.
• Change of any functional component as torsion or choc adapter
• Significant change in the patient's routine activities expected during the study.
• Progressive associated pathology that may prevent patient follow-up.
• Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... )
• No osteointegration patients
• Lack of consent
• Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
• Person not affiliated with or a beneficiary of a health insurance plan.
• Patient unable to understand the study instructions

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

PRO-FLEX PIVOT

Experimental group

Description:

The patient will be fitted with PRO-FLEX PIVOT® foot for a duration of 28 days, with a variance of ±2 days

Treatment:

Device: PRO-FLEX PIVOT Foot evaluation

Class III ESAR foot

Active Comparator group

Description:

The patient will be fitted with his usual class III ESAR foot for a duration of 28 days, with a variance of ±2 days

Treatment:

Device: Class III ESAR Foot evaluation